• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceNUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
400 inverness parkway,
suite 400
englewood, CO 80112
PMA NumberP840024
Supplement NumberS085
Date Received12/06/2002
Decision Date04/02/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the new r126 version 2 software and if6 card.
-
-